Abstract:

The characteristics and configuration of hepatocyte growthpromoting factor freeze-dried powder injection were studied with optical micrography and X-ray diffraction analysis，and the suitable freezedrying time of hepatocyte growthpromoting factor for injection was determined by the freezedrying testThe results indicated that the bulk drug and dextran had amorphous configurations and mannitol was crystalline and the freezedried powder included tiny mannitol crystals dispersed in the powder uniformlyThe crystal form of mannitol in the freezedried powder injection changed and the grains became tinierWhen the time for freezedrying was less than 30 h，the powder configuration was not homogeneousThe amorphous dextran was used as the protective agent and disperser for hepatocyte growthpromoting factor，the grains of mannitol constituted the framework of freezedried powder injectionIt was necessary to take 36 h to produce a good form of hepatocyte growthpromoting factor freezedried powder injection.

摘要： 借助X-衍射分析和显微成像研究促肝细胞生长素原药、辅料及冻干粉针剂的结构，结合对冻干制剂的含水量以及水溶解时限的测定，确定注射用促肝细胞生长素的合理冻干时间。结果表明，促肝细胞生长素原药和右旋糖酐溶液的冻干品为无定形结构，右旋糖酐不影响甘露醇的结晶，促肝细胞生长素多肽链干扰了甘露醇的结晶并使其晶型发生改变。当冷冻干燥时间低于30 h时，产品的组成是不均一的。因此，冻干粉针剂的结晶相由其中甘露醇的结晶构成，甘露醇的晶粒构成了粉针剂的骨架支撑材料，无定形的右旋糖酐是促肝细胞生长素的保护剂和分散剂，而形成性状良好的促肝细胞生长素冻干粉针剂所需冻干时间为36小时。